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Overtreatment of prostate cancer in the active surveillance era

Common Sense Family Doctor

in 2019, with 78% receiving radiation therapy and 22% undergoing surgery. times more likely to develop urinary or sexual complications, 2.78 times more likely to develop urinary or sexual complications, 2.78 Watchful waiting refers to clinical observation only. A recent analysis of the U.S. in 2000 to 59.8%

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The Most Engaging Decision You’ll Read All Year – Five Stars

FDA Law

If you made it through the first 2 pages of the opinion, this Court’s answer is clear: FDA flagrantly violated the APA in denying those flavored e-cigarette applications due to the Agency’s utter failure to provide comprehensible instructions and consistent policies. FDA also directed manufacturers to produce detailed marketing plans.

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The Mycoplasma Comeback: Why This Atypical Pneumonia is Back – A PEMCurrents Podcast

PEMBlog

Learning Objectives Describe the clinical presentation, epidemiology, and complications of Mycoplasma pneumoniae infections in pediatric patients, including its atypical manifestations. Clin Infect Dis 2019; 68:13. Plus, well discuss whether M. pneumoniae even needs to be treated in the first place! UpToDate , 1 Nov. Epub 2024 Aug 3.

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FDA Announces It Will Now Regulate Devices as Devices

FDA Law

As you may remember, Genus sued FDA back in 2019, alleging that FDA’s classification of, and putative regulation of, its barium sulfate products as drug products violated the FDCA because barium sulfate meets the statutory definition of medical device and therefore must be regulated as a device.

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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law

By Day 100 If MDUFA Decision is not reached by Day 100, FDA provides Missed MDUFA Decision Communication that identifies outstanding review issues. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 By Philip Won & Adrienne R. But that is only the beginning.

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FDA, in a RARE Act, Takes To Lobbying for a Change to the Orphan Drug Act

FDA Law

But in May 2019, FDA approved a second amifampridine drug product, Jacobus Pharmaceutical Company, Inc.’s And UFA reauthorization provides the perfect vehicle for the Agency to try and get this accomplished. Usually FDA’s lobbying activities are done rather quietly. Usually FDA’s lobbying activities are done rather quietly.

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An Arm and a Leg: The Prescription Drug Playbook, Part I

Physician's Weekly

Bob’s journey here begins in 2019 — the first day of high school for his daughter, Mary. In January of last year, Cole went to a Walgreens in Appleton, Wisconsin, to get refills on the medication he used to control his asthma. He’d been taking it for years, and he expected to pay about seventy bucks. He left without it.